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REMOGEN® Omega Versus Cationorm® in the Treatment of Patients Suffering From Dry Eye

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ClinicalTrials.gov Identifier: NCT03460548
Recruitment Status : Not yet recruiting
First Posted : March 9, 2018
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
TRB Chemedica

Brief Summary:
The efficacy and safety of Remogen® Omega in the treatment of dry eye signs and symptoms will be investigated in comparison to Cationorm®.

Condition or disease Intervention/treatment Phase
Dry Eye Device: Remogen Device: Cationorm Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicentre Randomized Trial Comparing the Efficacy and Safety of REMOGEN® Omega Versus Cationorm® in the Treatment of Patients Suffering From Dry Eye
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Remogen Device: Remogen
instil 1 drop of the product in each eye, 4 times per day

Active Comparator: Cationorm Device: Cationorm
instil 1 drop of the product in each eye, 4 times per day




Primary Outcome Measures :
  1. OSSF [ Time Frame: Day 28 ]
    Ocular surface staining with fluorescein (OSSF)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • With at least a 3-month documented history of bilateral dry eye
  • With a score of ocular surface staining with fluorescein (OSSF) ≥ 4 and ≤ 9 on the Oxford scale
  • With at least one objective sign of tear deficiency
  • With Ocular Surface Disease Index (OSDI) score of ≥ 18

Exclusion Criteria:

  • Refractive surgery within 12 months prior to selection
  • Any other ocular surgery or ocular trauma within 6 months prior to selection
  • Systemic or local use of one of the following medications: glucocorticosteroids, cyclosporine A, antibiotics, NSAIDs

Responsible Party: TRB Chemedica
ClinicalTrials.gov Identifier: NCT03460548     History of Changes
Other Study ID Numbers: TOGA-CT-1501
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Conjunctivitis
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Povidone
Plasma Substitutes
Blood Substitutes